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April 15, 2021

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Doubts over J&J one more snag for Europe

Europe鈥檚 choppy vaccine rollout hit more trouble yesterday after US drugmaker Johnson & Johnson delayed its COVID-19 shot and Denmark said it would drop a similar vaccine from AstraZeneca over the risk of blood clotting.

The European Medicines Agency was due to issue guidance on Johnson & Johnson later yesterday after US federal health agencies recommended pausing use of the vaccine for at least a few days after six women under 50 developed rare blood clots after receiving the shot.

Deliveries had already begun in some countries but authorities across the continent said they were suspending deployment or considering restricting use of the single-shot vaccine, pending further advice.

鈥淭he delivery of the J&J will take place, we will await the announcement of EMA and the FDA in the US,鈥 Marios Themistocleous, the official in charge of Greece鈥檚 pandemic response, said on state TV.

The delay came as a further blow to Europe鈥檚 faltering vaccinations campaign, which has been hit by problems ranging from poor coordination between national and regional authorities to procurement difficulties and a damaging contractual row with British-Swedish drugmaker AstraZeneca.

鈥淗ere we are in the hands of God: if it goes right it goes right, if it goes wrong it goes wrong. I don鈥檛 know, I don鈥檛 know what to say,鈥 said Rome resident Annamaria Gingaroli.

Earlier this month, European regulators said they had found a possible link between AstraZeneca鈥檚 COVID-19 vaccine and a similar rare blood clotting problem to the one connected to the Johnson & Johnson shot that led to a small number of deaths.

The EMA has recommended AstraZeneca鈥檚 vaccine, saying the benefits outweigh the risks, but several EU countries have limited its use to certain age groups and yesterday, Danish authorities said they were dropping the AstraZeneca vaccine.

鈥淭he Danish Health Authority has decided to continue the vaccination against COVID-19 without the vaccine from AstraZeneca,鈥 it said in a statement.

Although deliveries of the J&J shot had barely begun in Europe, questions about the two vaccines threaten to undermine public confidence in the low-cost jabs which authorities had been counting on as a central weapon in fighting a pandemic that has killed more than 3 million people.

An official from the US Food and Drugs Administration said it was 鈥減lainly obvious鈥 the J&J cases were 鈥渧ery similar鈥 to the AstraZeneca ones. He said no similar blood clot cases had been reported among recipients of the Moderna or Pfizer/BioNTech vaccines, which use a different technology.

J&J has said it is working closely with regulators and noted no clear causal relationship had been established between the events and its shot.

AstraZeneca was not immediately available for comment. It has said in the past it is working to understand individual cases of side-effects and 鈥減ossible mechanisms that could explain these extremely rare events.鈥

French government spokesman Gabriel Attal told a news conference yesterday the government remained confident in the AstraZeneca shot.

The potential risks with blood clots comes on top of an angry row between the European Commission and AstraZeneca, after the drugmaker delivered only a fraction of the vaccines ordered by Brussels.

Italian newspaper La Stampa reported that the Commission had decided not to renew COVID-19 vaccine contracts next year with AstraZeneca and J&J and would instead focus on vaccines using messenger RNA technology, such as Pfizer鈥檚 and Moderna鈥檚.

A spokesman for the EU Commission said it was keeping all options open for 2022 and beyond but declined to comment further.


 

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